Intracavity Ultrasound Probe Disinfectant System

ABSTRACT

A disinfectant system for intracavity ultrasound probes in disclosed generally including a housing, a disinfectant chamber positioned in the housing and receiving at least one ultrasound probe, a container for containing a disinfectant solution fluidly coupled to the disinfectant chamber, at least one pump for supplying the disinfection solution from the container to the disinfection chamber and from the disinfection chamber to the container, and a controller for automated operation of the disinfectant system, wherein the disinfectant solution is a multi-use disinfectant solution. A method for disinfecting intracavity ultrasound probes is also disclosed generally including placing at least one ultrasound probe into a disinfectant chamber, supplying a disinfectant solution from a container to the disinfectant chamber via a pump, and returning the solution to the container via the pump, wherein the steps of supplying and returning the disinfectant solution are controlled by a controller.

CROSS-REFERENCE TO RELATED APPLICATIONS

This patent application claims the benefit of, under Title 35, UnitedStates Code, Section 119(e), U.S. Provisional Patent Application No.61/365,915, filed Jul. 20, 2010, and U.S. Provisional Patent ApplicationNo. 61/365,917, filed Jul. 20, 2010.

FIELD OF THE INVENTION

This invention relates generally to disinfectant systems for medicaldevices. More specifically, the present invention relates to fullyautomated disinfectant systems for intracavity ultrasound probes.

BACKGROUND OF THE INVENTION

All medical instruments that come in contact with bodily fluids, such asblood, during medical procedures must be carefully disinfected toprevent harmful contamination. There are several types of disinfectantsthat are used to sterilize the medical instruments.

One of the common sterilization techniques used for medical devices issteam sterilization or autoclaving. This technique sterilizes medicalequipment by subjecting it to high pressure steam at 121° C. or more,typically for 15 to 20 minutes depending on the size of the medicaldevice. Typically, autoclave system includes a vacuum pump thatmechanically removes the air in the sterilizer, allowing it to be morequickly replaced with saturated steam. When the steam has displaced theair, the temperature and steam pressure build until the operatingtemperature is reached. This operating temperature, the temperature atwhich sterilization occurs, is maintained for the remainder of the cycletime.

However, autoclave sterilization systems are not suitable fordisinfection of heat sensitive medical devices because such devices canbe destroyed or have their useful lives severely curtailed by the hightemperature and pressures associated with the steam autoclave. The heatsensitive medical devices, therefore, are commonly disinfected usingliquid high level disinfectants rather than the cheaper and efficientmethod of steam autoclaving. The two main categories of such heatsensitive instruments are endoscopes and intracavity ultrasound probes.

Endoscopes are typically disinfected in automated washing machines thatdisinfect and rinse the endoscopes. There are several known automatedwashing machines marketed by different companies.

There are several kinds of intracavity ultrasound systems that havebecome increasingly popular due to their efficacy in providing usefulmedical information in a reasonably non-invasive manner. One of suchultrasound systems is a transvaginal ultrasound that uses an internalprobe, or transducer, that enters the vaginal cavity. An internal probeallows for closer access to the structures that need evaluation. Withcloser access, higher frequency sound waves can be used, which providesa clearer image due to better resolution. This technique is often usedto evaluate suspected cancer or abnormal growths in the femalereproductive system.

Another type of intracavity ultrasound that has become increasinglypopular is an endorectal ultrasound, also called transrectal ultrasound.The endorectal ultrasound is a special ultrasound technique in which thetransducer is directly inserted through the anus and into the patient'srectum. The sound wave echoes detected by the transducer are convertedby a computer into an image.

Both vaginal and rectal ultrasound probes are examples of heat sensitivemedical instruments that cannot be steam autoclaved. The current stateof the art in disinfecting such probes is to manually place anultrasound probe into a container filled with a high level disinfectantfor a certain period of time, usually specified by a manufacturer of thedisinfectant. This is then followed by several fresh water rinses toremove the high level disinfectant residue from the probe.

One of such systems is described in U.S. Pat. No. 6,132,691 to Coles.This patent discloses a manual station for disinfecting intracavityultrasound probes, such as vaginal and rectal ultrasound probes. Thestation includes housing and at least two containers replaceablypositioned in the housing and contain a disinfectant and a rinsingagent. The ultrasonic probes are manually placed in the container withthe disinfectant for soaking, and then in the container with the rinsingagent for rinsing.

However, there are a number of problems associated with knowndisinfecting systems for intracavity ultrasound probes. For example, onedisadvantage of known systems is that the disinfecting process must beperformed by an operator. The operator's variation in the performance ofthe process, such as mixing of the disinfectant solution, timing andequipment handling, raises problems of assurance and reproducibility ofthe manual disinfection process. Another disadvantage is that the systemoperator typically receives a prolonged exposure to harmful disinfectantfumes due to the time-consuming steps involved with the manualdisinfection of the ultrasound probes. Yet another disadvantage of thisknown system is that it utilizes a single-use disinfectant solution,which has to be discarded after each disinfection procedure, whichrenders the procedure very expensive and inefficient.

What is desired, therefore, is an improved disinfectant system forintracavity ultrasound probes that overcomes the problems associatedwith known disinfectant systems. What is also desired is a disinfectantsystem for intracavity ultrasound probes that does not require manualoperation by an operator thereby reducing harmful exposure todisinfectant fumes. What is further desired is a disinfectant system forintracavity ultrasound probes that is fully automated and thus moreaccurate. What is also desired is a disinfectant system for intracavityultrasound probes that is capable of reusing the disinfectant solutionthereby allowing for more a efficient and less costly disinfectionprocedure.

SUMMARY OF THE INVENTION

Accordingly, it is an object of the present invention to provide animproved disinfectant system for intracavity ultrasound probes thatovercomes the problems associated with known disinfectant systems.

It is another object of the present invention to provide an intracavityultrasound probe disinfectant system that is fully automated and morereliable.

It is a further object of the present invention to provide anintracavity ultrasound probe disinfectant system that does not requiremanual operation and thereby eliminates operator's exposure to harmfuldisinfectant fumes.

It is yet another object of the present invention to provide anintracavity ultrasound probe disinfectant system that is designed toutilize a multi-use disinfectant solution to achieve a more efficientand less expensive disinfection procedure.

In order to overcome the deficiencies of the prior art and to achieve atleast some of the objects and advantages listed, the invention comprisesan intracavity ultrasound probe disinfectant system including a housing,a disinfectant chamber positioned in the housing and receiving at leastone ultrasound probe, a container for containing a disinfectant solutionfluidly coupled to the disinfectant chamber, at least one pump forsupplying the disinfection solution from the container to thedisinfection chamber and from the disinfection chamber to the container,and a controller for automated operation of the disinfectant system,wherein the disinfectant solution is a multi-use disinfectant solution.

In some embodiments, the disinfectant solution is anortho-phthalaldehyde based disinfectant solution.

In certain embodiments, the disinfectant system also includes a fluidconduit for supplying a rinsing agent to the disinfectant chamber and adrain for discarding the rinsing agent from the disinfectant chamber. Insome of these embodiments, the rising agent is water. In some cases, thedisinfectant system also includes a filtration system for cleansing therinsing agent before it enters the disinfectant chamber.

In some embodiments, the disinfectant system further includes at leastone holder receiving an electrical component of the at least oneultrasound probe when the probe is positioned in the disinfectantchamber.

In certain embodiments, the disinfectant system also has a plurality ofvalves operated by the controller.

In some embodiments, the disinfectant system further includes at leastone sensor for measuring a quantity of the disinfectant solution withinthe disinfectant chamber. In certain of these embodiments, thecontroller controls the supply of the disinfectant solution to thedisinfectant chamber at least partially based on the calculatedquantity.

In some cases, the controller includes a processor for recording andstoring ultrasound probe profile data for later retrieval by a user.

In certain embodiments, the disinfectant chamber is removably positionedin the housing.

In some of these embodiments, the disinfectant chamber has a length thatis greater than a length of the at least one ultrasound probe. In someembodiments, the disinfectant chamber has an inner diameter greater thanan outer diameter of the at least one ultrasound probe.

In some cases, the disinfectant system also includes a heater positionedadjacent the container for maintaining a predetermined temperature ofthe disinfectant solution.

In certain embodiments, the disinfectant system further has an airfiltration system positioned within the housing and including an aircirculation fan and an air filter for deactivating harmful odorsgenerated by the disinfectant solution before discharging the air fromthe housing.

The invention also comprises a method for disinfecting intracavityultrasound probes, including the steps of placing at least oneultrasound probe into a disinfectant chamber contained within a housing,supplying a disinfectant solution from a container to the disinfectantchamber via a pump, and returning the disinfectant solution from thedisinfection chamber to the container via the pump, wherein the steps ofsupplying the disinfectant solution to the disinfectant chamber andreturning the disinfectant solution to the container are controlled by acontroller.

In some advantageous embodiments, the disinfectant solution comprises amulti-use disinfectant solution. In some of these embodiments, thedisinfectant solution comprises an ortho-phthalaldehyde baseddisinfectant solution.

In certain embodiments, the method further includes the steps ofsupplying a rinsing agent to the disinfectant chamber via a fluidconduit and discarding the rinsing agent from the disinfectant chambervia a drain, wherein said steps are controlled by the controller. Insome of these embodiments, the method also includes the step offiltering the rinsing agent before it enters the disinfectant chambervia a filtration system provided within the housing.

In some advantageous embodiments, the method further includes the stepof securing an electrical component of the at least one ultrasound probein at least one holder when the probe is positioned in the disinfectantchamber.

In certain embodiments, the method includes the steps of measuring aquantity of the disinfectant solution within the disinfectant chambervia at least one sensor and controlling the supply of the disinfectantsolution to the disinfectant chamber via the controller at leastpartially based on the calculated quantity.

In some embodiments, the steps of supplying the disinfectant solutionfrom the container to the disinfectant chamber and returning thedisinfectant solution from the disinfectant chamber to the container arerepeated.

In certain advantageous embodiments, the method also includes the stepof testing the disinfectant solution in the container to determine aminimum effective concentration of the solution.

In some embodiments, the method further includes the step of recordingand storing ultrasound probe profile data via the controller for laterretrieval by a user.

Other objects of the invention and its particular features andadvantages will become more apparent from consideration of the followingdrawings and accompanying detailed description.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a front perspective view of a disinfectant system inaccordance with the invention.

FIG. 2 is front perspective view of the disinfectant system of FIG. 1,showing the interior components of the system.

FIG. 3 is a side, partially cross-sectional view of the disinfectantsystem of FIG. 1.

DETAILED DESCRIPTION OF THE INVENTION

The present teachings are described more fully hereinafter withreference to the accompanying drawings, in which the present embodimentsare shown. The following description is presented for illustrativepurposes only and the present teachings should not be limited to theseembodiments.

As used in the description, the terms “top,” “bottom,” “above,” “below,”“over,” “under,” “above,” “beneath,” “on top,” “underneath,” “up,”“down,” “upper,” “lower,” “front,” “rear,” “back,” “forward” and“backward” refer to the objects referenced when in the orientationillustrated in the drawings, which orientation is not necessary forachieving the objects of the invention.

The disinfectant system of the present invention is particularlysuitable for disinfecting vaginal/rectal ultrasound probes. However, itshould be understood that other kinds of intracavity ultrasound probesmay be disinfected using the system and method of the present invention.

The disinfectant system for vaginal/rectal ultrasound probes is a unitthat encloses all the working parts in a single housing for ease ofoperation. The unit will preferably be placed on the floor and attachedto the wall to prevent the unit from falling forwards, although otherconfigurations are possible without departing from the spirit of theinvention. The housing includes a disinfection chamber that receives atleast one ultrasound probe. A container filled with a disinfectant isplaced in the lower part of the housing. The ultrasound probes aresuspended into the disinfection chamber and held in place by a strainrelief that holds the electrical cord at a pre-determined mark. Thedisinfectant is pumped into the disinfection chamber. After apre-determined time it is then pumped back into the container forfurther use. The probe is then rinsed with fresh water. The disinfectantsystem is connected to a fresh water supply and a drain via any suitableconnectors, e.g. quick disconnect fittings. The fresh water supply willpass through an external water filtration system that may include apre-filter for sediment followed by a bacteria retention filter of 0.02microns or better.

The disinfecting process is completely automated and is managed by anysuitable micro processor. The disinfectant system further includes acontrol panel that prompts the end user for each task involved in thedisinfecting process. The micro processor records and saves informationpertinent to an ultrasound probe to be disinfected, such as the probe IDnumber, date and time of disinfecting procedure and an outcome of thedisinfection cycle. This information may be later retrieved from thesystem by the end user.

The disinfectant system of the present invention may be used with anysuitable type of disinfectant solution. Preferably, the disinfectant isan FDA approved high-level disinfectant that is also approved by anultrasound probe manufacturer for use with their specific ultrasoundprobes. One of the advantages of such disinfectants is that they may bereused, therefore allowing for significant cost savings for the enduser. In one advantageous embodiment, the disinfectant system of thepresent invention is used with an ortho-phthalaldehyde (OPA) baseddisinfectant solution, which may be reused for up to twenty-eight days.

One advantageous embodiment of the present invention is illustrated inFIG. 1. Although the invention has been described with reference to aparticular arrangement of parts, features and the like, these are notintended to exhaust all possible arrangements or features, and indeedmany other modifications and variations will be ascertainable to thoseof skill in the art.

As shown in FIG. 1, the intracavity ultrasound probe disinfectant system(10) includes a housing (12), which contains all of the components ofthe system. The housing (12) includes an upper access point (14), suchas a door, and a lower access point (16). In the embodiment shown inthis figure, the housing (12) is placed directly on the floor and may befurther attached to the wall to prevent the unit from falling forward.However, it should be understood that other configurations, such assuspending the unit from the wall, are possible without departing fromthe spirit of the invention.

The disinfectant system (10) of the present invention is designed toaccommodate one or more ultrasound probes. FIG. 1 illustrates thedisinfectant system (10) with two ultrasound probes (11 a, 11 b) inplace. It is understood that the disinfectant system may accommodateonly one ultrasound probe, or more than two ultrasound probes, inaccordance with the present invention. Each of the ultrasound probes (11a, 11 b) has a cord section (13 a, 13 b), a probe section (not shown),and an electrical connector (15 a, 15 b).

As depicted in FIG. 1, the housing (12) also includes a strain relief(18) positioned above the upper door (14). The strain relief (18) has acurved shape to accommodate the placement of the probe cord section (13a, 13 b). However, any other suitable shape of the strain relief may beutilized, depending on a particular type of the ultrasound probe beingdisinfected. The strain relief (18) operates to engage the cord (13 a,13 b) to prevent it from slipping out.

A holder (20) is also provided for accommodating the electricalconnector sections (15 a, 15 b) of the ultrasound probes (11 a, 11 b).The holder (20) is placed outside of the housing (12) to protect theelectronics and prevent any exposure to the disinfectant solution. Inthe embodiment shown, the holder (20) is attached to a wall adjacent thehousing (12). It is noted, however, that the holder (20) may be attachedto an outside wall of the housing (12) adjacent the strain relief (18).The disinfectant system (10) may also include a cable sensor positionedadjacent to the strain relief (20) for sensing whether the probe cord(13 a, 13 b) is positioned in the strain relief (20).

FIGS. 2 and 3 illustrate the disinfectant system (10) of the presentinvention with the interior components of the housing (12) shown. Thehousing (12) contains a disinfection chamber (22) removably positionedin the upper part of the housing (12) and adapted for receiving at leastone ultrasound probe (11 a, 11 b). It is envisioned that thedisinfection chamber (22) may be removed from the housing (12) andreplaced by a different disinfection chamber to accommodate differenttypes of ultrasound probes. The housing (12) is shown with twoultrasound probes (11 a, 11 b) supportingly positioned within thedisinfection chamber (22). As discussed above, it is understood that thedisinfectant system (10) of the present invention may allow forsimultaneous disinfection of one or two or more intracavity ultrasoundprobes.

The disinfection chamber (22) may comprise a wide variety of shapes toaccommodate the shape of the intracavity ultrasound probes (11 a, 11 b)to be inserted therein. Preferably, the disinfection chamber (22) has anoverall length greater than the length of the ultrasound probes (11 a,11 b), and a diameter greater than the diameter of at least twoultrasound probes (11 a, 11 b) to allow for easy insertion of one ormore probes into the chamber. In one advantageous embodiment, thedisinfection chamber (22) has a cylindrical shape designed toaccommodate vaginal/rectal ultrasound probes, which are typicallyapproximately 12″ long and are made of a rigid plastic.

The disinfection chamber (22) may be formed from any commerciallyacceptable material, e.g. high-density polyethylene. The disinfectionchamber (22) may include a removable basket (not shown) to allow theuser to place loose items, e.g. biopsy guides, that require disinfectionto be disinfected at the same time as the ultrasound probe. Thedisinfection chamber (22) terminates in the upper access point or door(14), through which the ultrasound probes (11 a, 11 b) are introducedinto the chamber (22). The upper door (14) may be opened to allow theoperator to insert the probes (11 a, 11 b) into the chamber (22), andthen closed. The upper door (14) is provided with a sensor (24) thatconfirms that the upper door is open or closed. The disinfection chamber(22) may further include a plurality of sensors positioned inside thechamber (22) for sensing a quantity of a disinfectant solution withinthe chamber, as well as rinse level and overflow level. Any type ofsuitable sensors may be used in accordance with the present invention.

The disinfectant system (10) of the present invention further includes acontainer (26) removably placed in the lower portion of the housing(12). The container (26) contains a disinfectant solution and may be ofany commercially available size and shape. In one advantageousembodiment, the container (26) is a one gallon bottle of anortho-phthalaldehyde (OPA) high level disinfectant solution. Thecontainer (26) may include a screw cap and protective foil to preventcontamination and/or spillage of the disinfectant solution before use.

The container (26) is provided with a plug assembly (28) for removableattachment of the container (26) to the other components of thedisinfectant system (10). The plug assembly (28) may include a plug madefrom any suitable material, such as rubber, that tightly fits into anopening in the container (26). The plug assembly (28) may furtherinclude a rod that extends into the container (26) when inserted. Therod may be made from any suitable material, e.g. stainless steel. Theplug may further include an air release vent to expel an excess of airthat may accumulate in the container (26). Te plug assembly (28) alsoincludes a connection or fitting to allow the operator to quickly andeasily connect and disconnect the container (26) from the disinfectantsystem (10).

Once the container (26) is positioned within the housing (12) throughthe lower door (16), it is connected to a conduit leading to thedisinfection chamber (22) via the plug assembly (28). As depicted inFIG. 2, the conduit includes a disinfectant supply line (30) and adisinfectant drain line (32). The supply line (30) and the drain line(32) are made from any suitable material and may have differentdiameters and lengths depending on the size of the housing (12).

The disinfectant supply line (30) functions to supply the disinfectantsolution from the container (26) to the disinfection chamber (22). Apump (34) is connected to the supply line (30) for pumping thedisinfectant solution from the container (26) through valves (36 a, 36c) to the disinfection chamber (22). Any suitable commercially availablepump may be used in accordance with the present invention. The valves(36 a, 36 c) may be any suitable valve type, e.g. solenoid valve. Thevalves operate to open and close the supply line (30) during thedisinfection cycle.

The drain line (32) connects the bottom portion of the disinfectionchamber (22) with the container (26) and functions to drain thedisinfectant solution from the chamber through valves (36 c, 36 b) backto the container (26) for re-use. A pump (38) is placed in the drainline (32) for pumping the disinfectant solution from the disinfectionchamber (22) back to the container (26). As shown in FIG. 3, a liquidfilter screen (40) may be positioned in the bottom of the disinfectionchamber (22) to prevent any debris from blocking the valves (36 c, 36 b)and the pump (38) as the disinfectant solution drains from the chamber.The valves (36 b, 36 c) may be any suitable valve type, e.g. solenoidvalve. The valves operate to open and close the drain line (32) duringthe disinfection cycle.

As shown in FIG. 2, the disinfectant system (10) further includes awater supply line (42) connected to an external water supply. The watersupply line (42) is connected to a water pressure regulator (44) andthen to the disinfection chamber (22). The pressure regulator (44)functions to regulate the water pressure within the line (42). Any knownsuitable type of pressure regulator, such as a valve, may be used inaccordance with the present invention.

Two valves (48 a, 48 c) are positioned in the water supply line foropening and closing the line during the rinse cycle. In one possibleembodiment, the water supply line (42) is connected to the externalwater line via quick disconnect fitting or any other suitable connector.The disinfectant system (10) further includes a water drain line (46)connected to an external drain. The water drain line (46) includes apump (47) for pumping the water out of the disinfection chamber (22)during the rinse cycle through the valves (48 b, 48 c). As discussedabove, any suitable type of valves and pumps can be used withoutdeparting from the spirit of the present invention.

As depicted in FIG. 3, the disinfectant system (10) of the presentinvention also includes one or more heating devices to heat thedisinfectant solution to an optimal desired temperature. For example, aheating pad (50) may be positioned underneath the container (26) forheating the disinfectant solution contained therein. Temperature sensorsmay also be provided on the container (26) and the disinfectant chamber(22) for measuring the temperature of the disinfectant solution.

In accordance with one advantageous embodiment of the present invention,the disinfection process performed by the disinfectant system is fullyautomated and is controlled by a computer based electronic controlsystem. As shown in FIG. 2, all components of the intracavity ultrasounddisinfectant system (10) are activated and controlled by a control panel(52) provided on the top surface of the housing (12) and including acentral processing unit (CPU). The system may further include a displaymounted on the panel (52) for displaying information to the user. Thecontrol panel (52) includes a keypad to allow the user to inputinformation, such as an ultrasound probe identification number, time anddate. Any information inputted into the disinfection system by the user,as well as any information about the disinfection cycle, can be accessedand retrieved from the system at a later time. In some embodiments, theinformation may be downloaded by the user via any suitable memorydevice, such as a flash memory card, through a port (not shown) providedin the housing (12).

If desired, various sensors may be included in the disinfectant system(10) in accordance with the present invention to ensure proper operationof the system. For example, in the embodiment depicted in the figures, asensor (60) may be positioned adjacent the container (26). This sensoroperates to confirm that the container (26) is placed in the housing(12) before the commencement of the disinfecting cycle. Similarly, asensor may be provided in the upper portion of the housing (12) adjacentthe strain relief (18) to detect the ultrasound probe cords (13 a, 13 b)positioned in the housing. Additionally, as depicted in FIG. 2, thesensor (24) is provided in the upper door (14) for sensing an opened orclosed position of the door. Any known suitable types of sensors may beused in accordance with the present invention.

In one advantageous embodiment of the present invention shown in FIG. 2,the housing (12) is further provided with an air filtration system,which may incorporate air filters (54) that function to deactivate andremove harmful fumes generated by the disinfectant solution. The housing(12) also includes one or more exhaust fans (56) provided in the housingwall. The exhaust fans (56) are utilized to draw the vapor through thefilter (54) before recirculating the filtered vapor into the ambientsurroundings through an opening (58) in the housing wall.

One advantageous embodiment of the automated operation of theintracavity ultrasound probe disinfectant system of the presentinvention is described below. It would be appreciated by those skilledin the art that various changes and modifications can be made to thedescribed embodiment without departing from the spirit of the presentinvention. All such modifications and changes are intended to be coveredhereby.

The disinfectant system (10) is first plugged into an electric outlet.The user may mark the ultrasound probes according to an operator'smanual to ensure that the probes are at the correct position fordisinfection.

To prepare the disinfectant system for operation, the user will remove aclosure system, such as a screw cap and protective foil, from acontainer (26) of disinfectant solution and replace it with the plugassembly (28). The plug assembly (28) is inserted into the opening inthe container (26) and is tightly fitted therein via a plug. At leastone rod is extended from the plug assembly (28) into the disinfectantsolution in the container (26). Next, the user may place the container(26) with the plug assembly (28) into the lower portion of the housing(12) through the lower door (16). The plug assembly (28) is thenconnected to the internal plumbing via the fitting.

The disinfectant system (16) is then be switched ON using the ON/OFFswitch positioned on the wall of the housing (12). Switching on thesystem activates several operations. First, the control panel (52) willprompt the user to enter information regarding the disinfectantsolution, such as an expiry date for the solution. The expiry date isthe date the disinfectant solution must be discarded from the system.This prompt may appear only when a new container of disinfectantsolution is inserted. Then, the sensor (60) will sense that a containerof disinfectant (26) has been placed in the housing (12). Next, thelower heat pad (50) may be turned on to maintain a desired temperatureof the disinfectant solution within the container (26). At this point,the air filtration system, such as the fan (56), is turned on to filterthe disinfectant vapor through the filter (54) before it exits thehousing (12). The fan (56) may operate continuously when the system ispowered up.

The control panel (52) will then indicate to the user that the system isready for operation, for example, by showing ‘Ready for Use: PressEnter’ on the display. The control panel (52) will prompt the user toenter information relating to the ultrasound probe to be disinfected,such as the probe identification number. In one possible embodiment,each ultrasound probe that will be placed into the disinfectant system(10) will have a unique digit identification number. The CPU may alsoautomatically record the time and date, and may also record whether ornot there was a successfully completed disinfection cycle. All recordedinformation will be stored and may be later retrieved by the user viathe data port provided in the housing wall. The disinfection system (10)may also utilize an emergency back-up battery to maintain the recordedinformation.

Next, the control panel (52) will prompt the user to open the upper door(14). The sensor (24) will confirm that the door is open and will promptthe user to insert the ultrasound probes (11 a, 11 b). The user willthen place the electrical connectors (13 a, 13 b) of the ultrasoundprobes into the holder (20), and will then place the ultrasound probes(11 a, 11 b) into the disinfection chamber (22). The probes are insertedinto the disinfection chamber (22) and the electrical cords (13 a, 13 b)are placed over the curved strain relief (18). The user may align a markprovided on the electrical cords with a mark provided on the strainrelief to ensure that the probes are suspended to the correct height.The strain relief (18) prevents the cords (13 a, 13 b) from slipping.The sensor provided on the strain relief (18) confirms the cords are inplace. The disinfectant system (10) will not start without this step,and if the ultrasound probes (11 a, 11 b) are removed prior to the endof the disinfection cycle, the system will go into an ‘Abort Cycle,’described below.

After placing the ultrasound probes (11 a, 11 b) in the disinfectionchamber (22), the user will close the upper door (14), and press theSTART button to initiate the full cycle. The pump (34) will then turn onand pump the disinfectant solution from the container (26) into thedisinfectant chamber (22). A sensor positioned in the chamber (22) willsense that a desired level of the disinfectant is reached within thechamber, which turns off the pump (34). In one advantageous embodiment,a temperature sensor also positioned in the chamber (22) may confirmthat the minimum required temperature of the disinfectant solution hasbeen satisfied. The pre-determined disinfection period may not startunless the temperature is satisfied.

In certain advantageous embodiments, the control panel (52) will thenprompt the user to conduct a minimum effective concentration test (MECtest) to confirm the efficacy of the disinfectant solution. This test isperformed by utilizing a proprietary test strip. The door lower (16) isopened and the test strip is dipped into the disinfection solution. Notethat the display will show ‘Close Door’ when the door is opened duringthis process. The test strip is then compared to a color chart providedby the manufacturer to establish efficacy of the disinfectant solution.

The disinfectant solution will remain in the disinfection chamber (22)for a predetermined amount of time. After the predetermined disinfectiontime, the valves (36 b, 36 c) will open, the pump (38) will be turnedon, and the disinfectant solution will be pumped back into the container(26). A current detector on the pump (38) will sense the lower currentdraw of the pump, meaning that all liquid has been discharged from thedisinfection chamber (22) and will stop pumping and close valves (36 b,36 c).

After the disinfection cycle, the ultrasound probes (11 a, 11 b) arerinsed with a rinsing agent, such as fresh water, to ensure that noresidual levels of disinfectant are left on the probes. Immediatelyafter the valves (36 b, 36 c) close following the disinfection cycle,the valves (48 a, 48 c) will open. Another sensor positioned within thedisinfection chamber (22) will sense the correct rinse water level inthe chamber (22). In certain advantageous embodiments, the level of therinse water in the chamber (22) is higher than the disinfectant solutionlevel. The system will then turn off the valves (48 a, 48 c). The rinsewater will remain in the disinfection chamber (22) for a pre-determinedamount of time. After this time, valve (48 c, 48 b) will open and pump(47) will pump the water to drain via drain line (46). A currentdetector on pump (47) will sense the lower current draw of the pump,meaning that all liquid has been discharged from the disinfectionchamber and will stop pumping and close valves (48 c, 48 b). In oneadvantageous embodiment, the rinsing cycle is repeated three times toensure that the ultrasound probes are completely rinsed off. This willcomplete the disinfection and rinse cycles.

The control panel (52) will then inform the user that the disinfectioncycle is completed. For example, an ‘end of cycle’ message may bedisplayed on the control panel (52), and/or the user may be alerted by aflashing light or a sound. The alert signal may continue until theultrasound probes (11 a, 11 b) are removed from the housing (12). Thesensor positioned adjacent the strain relief will signal to the CPU thatthe probes have been removed, and the control panel (52) will inform theuser that the disinfection system is ready for further use, e.g. bydisplaying a ‘Ready for Use’ message on the display. The ultrasoundprobes may be left in the disinfectant system (10) until needed.

The following is a description of an exemplary method of operation ofthe intracavity ultrasound probe disinfectant system (10) in accordancewith one advantageous embodiment of the present invention.

Preparation

Factory Set Up:

1. Enter Date: Month/Day/Year.

2. Enter Time: Hour/Minute.

3. Save Settings.

Customer Set Up:

1. Measure and mark each probe's electrical cord according toinstructions in operators manual to ensure proper positioning of probein a disinfection chamber (22).

2. Plug the system into 110V outlet.

3. Enter disinfection time for a disinfectant solution.

Prepare for Use:

1. Remove a cap from a container with disinfectant solution (26).

2. Insert a plug assembly (28) into the container.

3. Open a lower door (16).

4. Place the opened container (26) with the plug assembly (28) into thehousing (12).

5. Connect to a fitting.

6. Close the lower door (16).

7. Switch the system ON, using ON/OFF switch. Following actions happenwhen the system is switched on:

-   -   a. A sensor (60) confirms that a full container (26) is in        place. The system will not begin operating without this step.    -   b. A heat pad (52) is energized to maintain a pre-determined        temperature using a built-in thermocouple.    -   c. Two fans (56) turn on and stay on as long as the system is        powered up.    -   d. A control panel (52) shows ‘Ready for Use: Press Enter.’

Unit Ready to Receive Probe:

1. Enter Probe ID into the control panel (52).

2. The system automatically records time and date. Battery back-up isprovided for time and date.

3. Open an upper door (14).

4. Place electrical connectors (15 a, 15 b) into an electrical connectorholder (20).

5. Place ultrasound probes (11 a, 11 b) into the disinfection chamber(22).

6. Place electrical cords (13 a, 13 b) of the probes (11 a, 11 b) over astrain relief (18).

7. A sensor confirms the cords in place. The system will not beginoperating without this step. The system will abort if the cord isremoved before end of the cycle.

8. Close the upper door (14). A sensor (24) confirms that the door isclosed.

9. Press START on the control panel (52). Start button is lighted.

Disinfection Cycle

Operation 1:

1. A pump (47) turns ON, valves (48 b, 48 c) open and the system runs afive second purge cycle.

2. A pump (34) turns ON, valves (36 a, 36 c) open, disinfectant solutionis pumped into the disinfection chamber (22).

Operation 2:

3. A sensor senses that a proper level of the disinfectant solution isreached in the chamber (22).

4. The pump (34) turns OFF and valves (36 a, 36 c) close.

5. A thermocouple reads temperature of the disinfectant solution in thechamber (22). The temperature must exceed the minimum requiredtemperature of the disinfectant to initiate the minimum soak time.

6. The minimum soak time starts after confirmation of the desiredtemperature and level is achieved.

7. The control panel (52) prompts the user to conduct a minimumeffective concentration test with a test strip.

Operation 3:

8. After a pre-determined soak time a valves (36 c, 36 b) OPEN.

9. A pump (38) pumps the disinfectant solution back to the container(26).

10. Current sensor on the pump (38) senses low current indicating liquidhas been removed from chamber (22).

11. Time delay to allow the liquid to drain to the container (26).

12. The pump (38) stops.

13. The valves (36 c, 36 b) CLOSE.

Rinse/Drain Cycle

Operation 1:

1. The valves (48 a, 48 c) OPEN allowing fresh water to flow into thedisinfection chamber (22).

2. The sensor senses water fill level in the chamber (22), which is tobe higher than the level of the disinfectant solution.

3. The valves (48 a, 48 c) CLOSE.

4. Rinse water remains in chamber (22) for pre-determined period.

5. The valves (48 b, 48 c) OPEN.

6. The pump (47) turns ON pumping rinse water to drain.

7. The valves (48 b, 48 c) CLOSE.

8. Current sensor on the pump senses low current indicating water hasbeen removed from chamber (22) and turned off pump (47).

9. This process is repeated three times.

End Of Cycle

1. Display shows ‘End of Cycle’ and emits beep and flashing light toalert the end user that the ultrasound probe is ready. This step willcontinue until the probes are removed from the chamber (22).

2. Sensor provided on the strain relief (18) tells the CPU that theprobes (11 a, 11 b) are removed and the display will show ‘Ready forUse: Press Enter’.

3. Information about the cycle is stored in the CPU and can be accessedby the user via a memory stick.

The disinfectant system of the present invention may incorporate varioussafety features to ensure a safe operation by the end user. If the levelof the disinfectant solution in the chamber (22) exceeds the normallevel, the sensor provided in the chamber (22) will stop the system andshow an error code on the display. This will require the operator topush the ‘Abort’ button, which will open valves (36 c, 36 b) and turn onpump (38) and pump disinfectant back to the container (26). Thedisinfection chamber (22) is preferably designed to hold approximatelyfifty percent less liquid than the disinfectant container (26).

The one advantageous embodiment, the disinfectant system (10) mayinclude an abort cycle. In the event that the sensors detect any kind ofmalfunction in the system, the disinfection system will flash an ‘ErrorCode, Service Required’ on the display and give an audible alarm. Enduser will call manufacturer to review Error Code, and then push the‘Abort’ key.

Depending on which cycle the device is in (i.e. disinfection or rinse),the disinfection solution will be returned to the container (26) or therinse water will be pumped to drain. These steps may be then followed bya full rinse cycle described above. At the end, the display will exhibitan ‘Abort Cycle Completed’ message. In order to proceed with thedisinfection cycle, the operator will need to remove the ultrasoundprobes (11 a, 11 b) from the housing (12) and then repeat all of thesteps of the cycle described above.

It would be appreciated by those skilled in the art that various changesand modifications can be made to the illustrated embodiment withoutdeparting from the spirit of the present invention. All suchmodifications and changes are intended to be covered hereby.

1. A disinfectant system for intracavity ultrasound probes, comprising:a housing; a disinfectant chamber positioned in said housing andreceiving at least one ultrasound probe; a container for containing adisinfectant solution fluidly coupled to said disinfectant chamber; atleast one pump for supplying the disinfection solution from saidcontainer to said disinfection chamber and from said disinfectionchamber to said container; and a controller for automated operation ofsaid disinfectant system; wherein the disinfectant solution is amulti-use disinfectant solution.
 2. The disinfectant system of claim 1,wherein the disinfectant solution comprises an ortho-phthalaldehydebased disinfectant solution.
 3. The disinfectant system of claim 1,further comprising a fluid conduit for supplying a rinsing agent to saiddisinfectant chamber and a drain for discarding the rinsing agent fromsaid disinfectant chamber.
 4. The disinfectant system of claim 3,wherein said rising agent is water.
 5. The disinfectant system of claim3, further comprising a filtration system for cleansing the rinsingagent before it enters said disinfectant chamber.
 6. The disinfectantsystem of claim 1, further comprising at least one holder receiving anelectrical component of said at least one ultrasound probe when saidprobe is positioned in said disinfectant chamber.
 7. The disinfectantsystem of claim 1, further comprising a plurality of valves operated bysaid controller.
 8. The disinfectant system of claim 1, furthercomprising at least one sensor for measuring a quantity of thedisinfectant solution within said disinfectant chamber.
 9. Thedisinfectant system of claim 8, wherein said controller controls thesupply of the disinfectant solution to said disinfectant chamber atleast partially based on the calculated quantity.
 10. The disinfectantsystem of claim 1, wherein said controller includes a processor forrecording and storing ultrasound probe profile data for later retrievalby a user.
 11. The disinfectant system of claim 1, wherein saiddisinfectant chamber is removably positioned in said housing.
 12. Thedisinfectant system of claim 1, wherein said disinfectant chamber has alength that is greater than a length of said at least one ultrasoundprobe.
 13. The disinfectant system of claim 1, wherein said disinfectantchamber has an inner diameter greater than an outer diameter of said atleast one ultrasound probe.
 14. The disinfectant system of claim 1,further comprising a heater positioned adjacent said container formaintaining a predetermined temperature of the disinfectant solution.15. The disinfectant system of claim 1, further comprising an airfiltration system positioned within said housing and including an aircirculation fan and an air filter for deactivating harmful odorsgenerated by the disinfectant solution before discharging the air fromsaid housing.
 16. A method for disinfecting intracavity ultrasoundprobes, comprising the steps of: placing at least one ultrasound probeinto a disinfectant chamber contained within a housing; supplying adisinfectant solution from a container to said disinfectant chamber viaa pump; and returning the disinfectant solution from said disinfectionchamber to the container via said pump; wherein the steps of supplyingthe disinfectant solution to said disinfectant chamber and returning thedisinfectant solution to the container are controlled by a controller.17. The method of claim 16, wherein the disinfectant solution comprisesa multi-use disinfectant solution.
 18. The method of claim 16, whereinthe disinfectant solution comprises an ortho-phthalaldehyde baseddisinfectant solution.
 19. The method of claim 16, further comprisingthe steps of supplying a rinsing agent to said disinfectant chamber viaa fluid conduit and discarding the rinsing agent from said disinfectantchamber via a drain, wherein said steps are controlled by saidcontroller.
 20. The method of claim 19, further comprising the step offiltering the rinsing agent before it enters said disinfectant chambervia a filtration system provided within said housing.
 21. The method ofclaim 16, further comprising the step of securing an electricalcomponent of said at least one ultrasound probe in at least one holderwhen said probe is positioned in said disinfectant chamber.
 22. Themethod of claim 16, further comprising the steps of measuring a quantityof the disinfectant solution within said disinfectant chamber via atleast one sensor and controlling the supply of the disinfectant solutionto said disinfectant chamber via said controller at least partiallybased on the calculated quantity.
 23. The method of claim 16, whereinthe steps of supplying the disinfectant solution from the container tosaid disinfectant chamber and returning the disinfectant solution fromsaid disinfectant chamber to the container are repeated.
 24. The methodof claim 16, further comprising the step of testing the disinfectantsolution in the container to determine a minimum effective concentrationof the solution.
 25. The method of claim 16, further comprising the stepof recording and storing ultrasound probe profile data via saidcontroller for later retrieval by a user.